The Food and Drug Administration Agency (FDA) ordered the popular asthma and allergy medication, montelukast (Singulair) warn in the packaging about its potential adverse effects that include neuropsychiatric disorders such as depression , hostility, anxiety, hallucinations, suicidal thoughts and agitation.
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The call boxed warning It is the highest warning required by the FDA to inform patients about potential dangers of any medication. ” The incidence of neuropsychiatric events associated with Montelukast is unknown, but some reports are serious and many patients and doctors are not aware of these risks. ”, explains Sally Seymor, spokesman for the agency in a statement.
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The decision was made in the light of infinity reports of neuropsychiatric events associated with montelukast that they received through the Agency’s Adverse Effects Reporting System and other studies published in the medical literature. From them they concluded that the medication should not be prescribed unless there are no other options available. “There are many other safe medications to treat allergies with a long history of safety in use and many of which are available without a prescription,” adds Seymor.
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9.3 million patients received a prescription for montelukast in the United States. 2.3 million of them are under 17 years old.
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What to do?
If you or your child take this medication, consult your doctor immediately if you notice behavioral changes such as agitation (including hostility or aggressive behavior), attention problems, nightmares, depression, disorientation, anxiety, hallucinations, irritability, memory problems , restlessness, sleepwalking, suicidal thoughts or uncontrollable muscle movements.
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“All medicines have side effects. It is important to differentiate if your child is taking montelukast for asthma or for allergy, if you use it for allergy there are many good options if you are worried about this warning, ”explains Michael Scaiss Mommy, director of the American Academy of Asthma and Immunology , clarifying that if it is used for asthma, it is best to consult with the pediatrician and take into account the medical and family history when making the decision.
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